Drug Target Review

APRIL 7, 2025

For example, transcriptomic processes are showing the potential to identify and track failures in gene expression and gene regulation of amyloid and tau-related biomarkers, understood as precursors to the onset of Alzheimers disease (AD). Trial design and statistical methods are also key to determining the utility and validity of biomarkers.

Clinical Development 69

Clinical Development Clinical Trials Clinical Pharmacology Trials 69

Drug Patent Watch

DECEMBER 30, 2024

Key Requirements for Generic Drug Approval Bioequivalence Studies : The PMDA requires bioequivalence studies to ensure that the generic drug is equivalent to the RLD in terms of its pharmacokinetic and pharmacodynamic properties. Clinical Pharmacology & Therapeutics , 111(3), 531538. Pharmaceutical Regulations in Japan 2020.

Drug Development 52

Drug Development Clinical Pharmacology Clinical Trials Pharmaceutical Companies 52

Alta Sciences

FEBRUARY 19, 2025

Beyond bioanalysis, understanding the mechanism of action is equally important, as different classes of oligonucleotidessuch as antisense oligonucleotides (ASOs)interact with mRNA in distinct ways to regulate gene expression. Our experts stay up to date on all new and evolving regulations to guarantee regulatory compliance in your studies.

Drug Development 52

Drug Development Clinical Pharmacology Immune Response Drugs 52

The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways. food effect, smoking, and drug-drug interactions) on drug exposure and response.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Pharmacokinetics Drugs 52

Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The committee also made recommendations regarding pharmacokinetic and safety assessments.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Agency IQ

FEBRUARY 23, 2024

I’m not going to say which one is better,” said JIANG LIU, scientific lead at the FDA’s Division of Pharmacometrics in the Office of Clinical Pharmacology. Then, a bit later but still in early-phase studies, developers can leverage this pharmacology information in innovative approaches that may incorporate modeling. . …

Science 40

Science FDA Trials Clinical Pharmacology 40

Agency IQ

JULY 28, 2023

FAR regulations require contracting officers to “promote and provide for full and open competition in soliciting offers and awarding Government contracts.” This proposal is an exciting example of how new approaches at the forefront of clinical pharmacology can be leveraged to address the problems being discussed in other forums (e.g.,

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40